Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU (QUALIFY)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Begins enrollment this month

Conditions: Prostate Cancer

Treatments: Procedure: Total prostatectomy; Procedure: Focal HIFU

Study type: Interventional

Funder types: Other

Identifiers

NCT06945172

2024-A02716-41 (Other Identifier)

Details and patient eligibility

About

The goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is:

What is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal HIFU ?

Researchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal HIFU to see their quality of life.

Participants will answer EPIC-CP questionnaire 6 months, 12 months and 24 months after treatment

Enrollment: 102 estimated patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient, male, aged between ≥ 40 and ≤ 75 years
• Patient with a life expectancy > 10 years at the time of inclusion.
• Patient with a therapeutic strategy (prostatectomy or focal HIFU) defined during a PCR.
• Patient with a diagnosis of localised prostate cancer at favourable intermediate risk
• Patient able to tolerate general anaesthesia or type IV sedation
• Patient with normal urinary continence status
• Patient with satisfactory erectile function allowing penetration:
• Patient with targeted biopsies and systematic biopsies
• Patient affiliated to or benefiting from a social security scheme
• French-speaking patients who do not object to the use of their data.

Exclusion criteria

• Patients with a contraindication to MRI
• Stage T3a or b on MRI
• Patient on long-term anticoagulants and unable to stop them.
• Patient already included in another study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Total prostatectomy

Active Comparator group

Description:

Patient will undergo total prostatectomy as a treatment for their cancer

Treatment:

Procedure: Total prostatectomy

Focal HIFU

Experimental group

Description:

Patient will undergo focal HIFU as a treatment for their cancer

Treatment:

Procedure: Focal HIFU